Director, Regulatory Science

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Contract – Director, Regulatory Science

Key Responsibilities

• Develop and deliver regulatory strategy across drug development programs, ensuring alignment with company goals and competitive landscape
• Ensure consistent regulatory advice and decision-making across programs, incorporating learnings from one program into all others
• Anticipate upcoming regulatory needs and ensure programs are fully resourced for applicable stages of development
• Lead and mentor direct reports, supporting professional development and performance
• Establish cross-functional partnerships with Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality, and other functions to drive alignment and team effectiveness
• Integrate expert feedback and competitive intelligence into regulatory strategy

Qualifications

• Degree in life sciences, pharmacy, medicine, or related field; advanced degree preferred
• Minimum 12 years in pharmaceutical/biotech industry; minimum 8 years in Regulatory Affairs including strategy and leadership roles
• Demonstrated success leading global regulatory submissions
• Direct experience in oncology drug development
• Experience with combination studies, multiple expansion cohort, basket/umbrella, or master protocols preferred
• Prior NDA experience preferred
• Strong cross-functional collaboration and senior leadership communication skills
• Ability to manage multiple programs simultaneously under tight timelines

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